The company, which is headquartered in Singapore, specialized in providing consultancy for medical device, in vitro diagnostic device (IVD) and HealthTech (digital health & AI) sector.
Services the Singapore company provides:
● Regulatory & quality compliance (ISO13485, EU Medical device regulation (MDR),medical device single audit program (MDSAP))
● Clinical trial management.
● Reimbursement & health economic/pricing
● Market access and distribution search
● Intellectual Property (IP) management
Translating concepts to final product from R&D to commercialization
Registering a new medical device in the Asian market is a complicated and drawn out process. The Singapore firm helps companies wade through the complicated approval process. The Singapore company has a complete ecosystem that has enabled the company to successfully register more than 5,880 medical device products for clients (MNCs & SMEs) in 18 countries in Asia.
Countries/Territories the company covers:
● East Asia (China, Hong Kong, Macau, Taiwan, Japan, South Korea)
● South Asia (India, Bangladesh, Sri Lanka)
● South East Asia (Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Brunei, Myanmar, Laos, Cambodia)
● Oceania (Australia, New Zealand)
The Singapore company is looking to offer their service to European partners especially partners in the medical device industry sector.
The Singapore company wishes to offer their services to European partners to help them establish a presence in the Asia Pacific market.